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Consumer Preference Study of Two Formulations of Phenylephrine Hydrochloride (Study CL2008-15)(P07530)(COMPLETED)

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vasomotor Rhinitis; Seasonal Allergic Rhinitis

Intervention: Phenylephrine Hydrochloride (HCl) Extended Release (ER) Tablets 30 mg (Drug); Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer


This is a randomized, two-way crossover, multicenter study evaluating the consumer preference of Phenylephrine Extended Release Tablets, 30 mg to be taken as one tablet every 12 hours, or Phenylephrine Immediate Release Tablets, 10 mg to be taken as one tablet every 4 hours in subjects with at least mild allergic rhinitis and nasal congestion. Approximately 250 participants will complete a questionnaire after taking one test product for 3 days followed by a 3 day ( 1 day) washout period; and then taking the alternate test product for 3 days. Analysis of which product the consumer preferred, if any, and which product was more convenient, if any, will be evaluated.

Clinical Details

Official title: A Randomized, Two-Way Crossover, Multicenter, Consumer Preference Study of Two Oral Formulations of Phenylephrine Hydrochloride.

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Percentage of Participants That Preferred Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets for the Relief of Nasal Congestion

Secondary outcome: Percentage of Participants That Preferred the Convenience of Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Healthy male or female volunteers must be 18 years or older.

- Participants must be willing to stop use of current decongestant and allergy

medications during the study, and at the start of the run-in period (Visit 2).

- Participants must have a documented history of allergic rhinitis caused by ragweed

allergen for at least the prior two years.

- Participants must have a documented skin testing (prick with wheal >= 3 mm larger

than the diluent or intradermal with wheal >=7 mm larger than the diluent control) or a positive in vitro test for specific IgE to the ragweed allergen within the last four years.

- Participants must have signs by clinical evaluation and symptoms of nasal congestion

of at least mild severity (sign/symptom clearly present, but minimal awareness; easily tolerated) at Visit 3 following the run-in period and at visit 5 following the washout period.

- Clinical laboratory tests (complete hematology, blood chemistries, urinalysis) must

be within normal limits or clinically acceptable to the Investigator/Sponsor. Sponsor will not grant waivers.

- Participants must have a seated (after 5 minutes of rest) systolic/diastolic blood

pressure ≤ 138/88 mmHg.

- Participants must have normal or clinically acceptable physical exam and

electrocardiogram (ECG) on 12-lead ECG (recorded at 25 mm/s).

- Participants must be free of any clinically significant disease that requires a

physician's care and/or would interfere with study evaluations, procedures or participation.

- Participants must agree not to take monoamine oxidase inhibitor (MAOI) for 14 days

before study participation and 14 days after the end of the study.

- Participants must be willing to give written informed consent (prior to any study

related procedures being performed) and able to adhere to restrictions and examination schedules.

- Female participants of childbearing potential (a non-menopausal female who has not

had a hysterectomy, bilateral oophorectomy, or medically documented ovarian failure, including a young woman who has not yet started menstruating) must be using medically acceptable (documented failure rate of less than 1%) birth control measures. Examples of medically acceptable contraception include hormonal contraceptives, intrauterine device (IUD), double-barrier method (any combination of male or female condom, diaphragm, spermicidal gel, sponge) or sterilization.

- Participants must be able to read and write English, and must understand the dosing

schedule. Exclusion Criteria:

- Participants must not have any significant medical condition which, in the judgment

of the investigator, is a contraindication to the use of phenylephrine HCl, might interfere with the study or requires treatment expected to affect the blood pressure. These may include thyroid disease (e. g. hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease, elevated intraocular pressure, prostatic hypertrophy, etc.

- Participants that have received allergen immunotherapy or Xolair (omalizumab) therapy

within the past two years.

- Participants who have a history of any clinically significant local or systemic

infectious disease within four weeks prior to initial treatment administration.

- Participants who have participated in a clinical trial of an investigational

treatment within 30 days prior to the start of the study (Run-in Period Day 1).

- Participants who are, appear to be, or are known to be, current or former addicts or


- Participants who have a known allergy or intolerance to phenylephrine HCl, any other

decongestant, loratadine, desloratadine or any other antihistamine.

- Females who are pregnant, nursing or unwilling to use/practice medically acceptable

contraception (documented failure rate of less than 1%).

- Participants with a history of asthma, rhinitis medicamentosa, or acute or chronic


- Participants that have used use of inhaled, oral, rectal, topical, intramuscular,

and/or intravenous potent chronic or intermittent corticosteroids (up to 1% topical hydrocortisone is permitted).

- Participants who work at the study site and/or for the Investigator or are family

members of study staff and/or the Investigator.

Locations and Contacts

Additional Information

Starting date: August 2009
Last updated: February 20, 2015

Page last updated: August 23, 2015

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